Device for driving fixation elements into bone and method of use thereof

ABSTRACT

A implanting device for driving a fastener or fixation element into bone is described. Also described are methods for using a implanting device for driving a fastener or fixation element into bone and a kit comprising a pneumatic implanting device for driving a fastener or fixation element into bone.

This application is a continuation application of U.S. patentapplication Ser. No. 14/644,838, filed Mar. 11, 2015, which claims thepriority of U.S. Provisional Application Ser. No. 62/051,094, filed Sep.16, 2014. The entirety of the aforementioned application is incorporatedherein by reference.

FIELD

This application generally relates to medical devices. In particular,the application relates to a device for implanting fixtures into bone.

BACKGROUND

Complex and simple fractures of bones have been found to heal morequickly and efficiently when the fragments are held together withfixation elements such as Kirschner wires (k-wires) or intramedullarynails (IM nails). However, at times it can be difficult to insertfixation elements into the bone quickly enough or with sufficient forcein order to make effective contact between the bone fragments in areduced fracture.

The present application provides a device for effectively and rapidlydriving fasteners and fixation elements into bone tissue using pneumaticpressure.

One aspect of the present application relates to an implanting devicefor driving a fastener or fixation element into bone, comprising: achamber for holding at least one fastener or fixation element, a barrelhaving a proximal end and a distal end, wherein said proximal end isconnected to said chamber for propelling said fastener or fixationelement from said chamber, a propulsion source functionally connected tosaid chamber, and a triggering mechanism for releasing propellant fromsaid propulsion source into said chamber and charging said chamber inorder to propel said fastener or fixation element from said chamberthrough said barrel and driving said fastener or fixation element intobone contacted with said distal end.

Another aspect of the present application relates to a pneumaticimplanting device for driving a fastener or fixation element into bone,comprising: a chamber for holding at least one fastener or fixationelement, a barrel having a proximal end and a distal end, wherein saidproximal end is connected to said chamber for propelling said fasteneror fixation element from said chamber, a gas source functionallyconnected to said chamber, and a triggering mechanism for releasingpropellant gas from said gas source into said chamber and charging saidchamber in order to propel said fastener or fixation element from saidchamber through said barrel and driving said fastener or fixationelement into bone contacted with said distal end.

Another aspect of the present application relates to a method for thefixation of a fractured long bone with an intramedullary nail,comprising: providing an access point to the medullary canal of saidlong bone, reducing the bone fragments at the fracture, contacting thedistal end of the barrel of an implanting device for driving a fasteneror fixation element into bone with said access point, aligning thebarrel of said device with said medullary canal at said access point,and actuating the trigger mechanism of said implanting device to deliveran IM nail into said medullary canal, thereby fixing said bone fragmentsin said reduced state, wherein said implanting device for driving afastener or fixation element into bone comprises: a chamber for holdingat least one fastener or fixation element, a barrel having a proximalend and a distal end, wherein said proximal end is connected to saidchamber for propelling said fastener or fixation element from saidchamber, a propellant source functionally connected to said chamber, anda triggering mechanism for releasing propellant from said propellantsource into said chamber and charging said chamber in order to propelsaid fastener or fixation element from said chamber through said barreland driving said fastener or fixation element into bone contacted withsaid distal end.

Still another aspect of the present application relates to a method forthe fixation a fractured bone using at least one k-wire, comprising:reducing at least one bone fragment with at least one adjacent fragmentor the main body of the bone, contacting the distal end of the barrel ofan implanting device for driving a fastener or fixation element intobone with said at least one bone fragment, said at least one adjacentfragment or said main body of the bone, aligning the implanting devicewith said at least one bone fragment and said at least one adjacentfragment or said main body of the bone, and actuating the triggermechanism of said implanting device to deliver a k-wire affixing said atleast one bone fragment to said at least one adjacent fragment or themain body of the bone, thereby fixing said at least one bone fragment insaid reduced state, wherein said implanting device for driving afastener or fixation element into bone comprises: a chamber for holdingat least one fastener or fixation element, a barrel having a proximalend and a distal end, wherein said proximal end is connected to saidchamber for propelling said fastener or fixation element from saidchamber, a propulsion source functionally connected to said chamber, anda triggering mechanism for releasing propellant from said propulsionsource into said chamber and charging said chamber in order to propelsaid fastener or fixation element from said chamber through said barreland driving said fastener or fixation element into bone contacted withsaid distal end.

Yet another aspect of the present application relates to a kitcomprising an implanting device for driving a fastener or fixationelement into bone and a fastener or fixation element, wherein saidimplanting device for driving a fastener or fixation element into bonecomprises: a chamber for holding at least one fastener or fixationelement, a barrel having a proximal end and a distal end, wherein saidproximal end is connected to said chamber for propelling said fasteneror fixation element from said chamber, a propellant source functionallyconnected to said chamber, and a triggering mechanism for releasingpropellant from said propellant source into said chamber and chargingsaid chamber in order to propel said fastener or fixation element fromsaid chamber through said barrel and driving said fastener or fixationelement into bone contacted with said distal end.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate one or more embodiments of thepresent application and, together with the written description, serve toexplain the principles of exemplary embodiments of the presentapplication.

FIG. 1 shows an embodiment of the device of the present application.

DETAILED DESCRIPTION

The following detailed description is presented to enable any personskilled in the art to make and use the device. For purposes ofexplanation, specific nomenclature is set forth to provide a thoroughunderstanding of the present device and methods. However, it will beapparent to one skilled in the art that these specific details are notrequired to practice the making or use of the device. Descriptions ofspecific applications are provided only as representative examples. Thepresent device and methods are not intended to be limited to theembodiments shown, but is to be accorded the widest possible scopeconsistent with the principles and features disclosed herein.

One aspect of the present application relates to an implanting devicefor inserting fasteners and fixation elements into a bone. The presentdevice propels a projectile in order to introduce a fixation implantinto a bone, either in a percutaneous or in an open (exposed bone)manner.

As used herein, “reduction,” “reduced” and “reducing” refer to a medicalprocedure to restore a fracture to the correct alignment by moving thefragments into contact with one another in the correct position for bonehealing.

A “fastener,” as used herein, refers to an element that partially embedsinto bone or hard tissue to fasten or anchor ligament, tendon or suturematerial to the bone. Examples of fasteners include, but are not limitedto suture anchors, pins, screws and staples. Fasteners of the presentapplication can be composed of metal, plastic, bioabsorbable material,ceramic, other suitable material or combinations thereof.

A “fixation element,” as used herein, refers to an element thatcompletely partially embeds into bone, bone fragments or hard tissue tofasten in order to immobilize reduced bone fragments in a position wherethe fragments can grow together. Examples of fixation elements include,but are not limited to k-wires and IM nails. Fixation elements of thepresent application can be composed of any suitable biocompatiblematerial including, but not limited to, metal alloys, plastic,bioabsorbable material, ceramic, or combinations thereof.

The device of the present application can be used to drive fasteners orfixation elements into and immobilize fragments of any fractured bone ina mammalian body. In a particular embodiment, said mammal is a human.

In particular embodiments, the bone is a long bone, having a shaft andtwo extremities. Long bones are found in the limbs and include theclavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal andmetatarsal bones, including the phalanges.

As used herein, the “proximal” end of a long bone refers to theextremity of the bone closest to the center of the body when the limb isextended. As used herein, the “distal” end of a long bone refers to theextremity of the bone farthest from the center of the body when the limbis extended. The device of the present application may be used toimmobilize the fragments of a fracture at the proximal end of a longbone, the distal end of a long bone, or the shaft of a long bone, or acombination thereof.

As used herein, the “proximal” end of a device, or a part of a device,is the end that is towards the practitioner holding or operating thedevice. As used herein, the “distal” end of a device, or a part of adevice, is the end that is towards the subject into whom a fastener isto be delivered.

As used herein, the “distal” end of a fastener is the end of thefastener that is oriented towards the subject into whom the fastener isto be delivered, i.e., the end of the fastener that makes the initialcontact with the bodily tissue of the subject. As used herein, the“proximal” end of a fastener is the end of the fastener that is oppositethe “distal” end of the fastener.

In other particular embodiments, the device of the present applicationcan be used to immobilize the fragments of a fractured short bone,including the patella, sesamoid, carpal and tarsal bones.

In further particular embodiments, the device of the present applicationcan be used to immobilize the fragments of a fractured flat bone,including the skull, cranium, occipital, parietal, frontal, nasal,lachrymal, vomer, scapula, os innominatum, sternum, and rib bones.

In additional particular embodiments, the device of the presentapplication can be used to immobilize the fragments of a fracturedirregular bone, including the vertebrae, sacrum, coccyx, temporal,sphenoid, ethmoid, malar, superior maxillary, inferior maxillary,palate, inferior turbinated, and hyoid bones.

One aspect of the present application relates to a pneumatic implantingdevice for driving a fastener or fixation element into bone. The devicecomprises a chamber for holding at least one fastener or fixationelement, a barrel having a proximal end and a distal end, wherein saidbarrel is for the delivery of the fastener or fixation element intobone, and a triggering mechanism for releasing a propulsion source.

In some embodiments, said fastener or fixation element is selected fromthe group consisting of a Kirschner wire (k-wire), an intramedullarymail (IM nail) or a suture anchor.

In one embodiment of the device, said proximal end of the barrel isconnected to said for propelling said fastener or fixation element fromsaid chamber, a propulsion source functionally connected to saidchamber, and a triggering mechanism for releasing propellant from saidpropulsion source into said chamber and charging said chamber in orderto propel said fastener or fixation element from said chamber throughsaid barrel and driving said fastener or fixation element into bonecontacted with said distal end.

In another embodiment, the device further comprises a replaceablecartridge for containing said at least one fastener or fixation elementin said chamber. In a further embodiment, said cartridge is disposable.In another further embodiment, said cartridge contains more than onefastener or fixation element.

In another embodiment, said propellant is a gas and said propulsionsource is a gas source. In some further embodiments, said gas source isa tube that connects to an external gas supply. In yet another furtherembodiment, said gas source is a replaceable canister of compressed gas.In a related embodiment, said compressed gas is medical grade air.

In still another embodiment, said propulsion source is an explosivematerial and said propellant is the explosion of said explosivematerial.

In particular embodiments, the device comprises a piston for propellinga fastener or fixation element from the chamber, through the barrel fromthe proximal to the distal end and into the bone. In some embodiments,the piston has a proximal and a distal end and the distal end comprisesa concave depression, cup, slot or other female-type feature into whichthe proximal end of the fastener or fixation element inserts or locatesin order to secure and/or center the fastener or fixation elementagainst the piston. In some embodiments, the pressure of the propellantbuilds up proximal to the piston in order to propel said piston in adistal direction when the triggering mechanism is actuated.

In further embodiments, the piston comprises a retainer mechanism thatprevents the piston from exiting the distal end of the barrel. In otherembodiments, the piston is shaped such that the distal-most portionthereof protrudes from the barrel upon delivery of the fastener orfixation element into bone.

In other particular embodiments, the device lacks a piston, wherein thefastener or fixation element fits into the barrel in such a manner thatthe propellant is contained in contact with and proximal to the fasteneror fixation element. Upon actuation of the triggering mechanism, saidpropellant drives said fastener or fixation element in a proximal todistal direction down the barrel into bone.

In another embodiment of the device, the device comprises a compressedor loaded spring located proximal to said chamber as a propulsion sourceand the release of the spring from compression or loading is thepropellant for driving said at least one fastener or fixation elementthrough said barrel into bone. In particular embodiments, the devicecomprising a compressed or loaded spring further comprises a piston forpropelling a fastener or fixation element from the chamber, through thebarrel from the proximal to the distal end and into the bone. In someembodiments, the piston has a proximal and a distal end and the distalend comprises a concave depression, cup, slot or other female-typefeature into which the proximal end of the fastener or fixation elementinserts or locates in order to secure and/or center the fastener orfixation element against the piston. In some embodiments, the tension ofthe compressed or loaded spring builds up proximal to the piston inorder to propel said piston in a distal direction when the triggeringmechanism is actuated. In further embodiments, the piston comprises aretainer mechanism that prevents the piston from exiting the distal endof the barrel. In other embodiments, the piston is shaped such that thedistal-most portion thereof protrudes from the barrel upon delivery ofthe fastener or fixation element into bone. In other particularembodiments, the device comprising a compressed or loaded spring lacks apiston, wherein the fastener or fixation element fits into the barrel insuch a manner that the compressed or loaded spring is in contact withand proximal to the fastener or fixation element. Upon actuation of thetriggering mechanism releasing the spring, said compressed or loadedspring drives said fastener or fixation element in a proximal to distaldirection down the barrel into bone.

In another embodiment of the device, the device comprises a stretchedelastic element and the contraction of said elastic element is thepropellant for driving said at least one fastener or fixation elementthrough said barrel into bone. In particular embodiments, the devicecomprising a stretched elastic element further comprises a piston forpropelling a fastener or fixation element from the chamber, through thebarrel from the proximal to the distal end and into the bone. In someembodiments, the piston has a proximal and a distal end and the distalend comprises a concave depression, cup, slot or other female-typefeature into which the proximal end of the fastener or fixation elementinserts or locates in order to secure and/or center the fastener orfixation element against the piston. In some embodiments, the tension ofthe stretched elastic element builds up proximal to the piston in orderto propel said piston in a distal direction when the triggeringmechanism is actuated. In further embodiments, the piston comprises aretainer mechanism that prevents the piston from exiting the distal endof the barrel. In other embodiments, the piston is shaped such that thedistal-most portion thereof protrudes from the barrel upon delivery ofthe fastener or fixation element into bone. In other particularembodiments, the device comprising stretched elastic element lacks apiston, wherein the fastener or fixation element fits into the barrel insuch a manner that the stretched elastic element is in contact with andproximal to the fastener or fixation element. Upon actuation of thetriggering mechanism, said stretched elastic element drives saidfastener or fixation element in a proximal to distal direction down thebarrel into bone.

In still another embodiment of the device, the device comprises afriction mechanism for driving a fastener or fixation device in aproximal to distal direction down the barrel and into bone. In someembodiments, said friction mechanism comprises at least one wheel thatcontacts the side of said fastener or fixation device, wherein rotationof said at least one wheel drives said fastener or fixation device in aproximal to distal direction down the barrel and into bone. In someembodiments, the device comprises two wheels that are opposite oneanother, gripping said fastener or fixation device between them. In someembodiments, the at least one wheel is made from a flexible materialincluding, but not limited to, silicon, rubber, latex, plastic or acombination thereof, including embodiments wherein one material islayered upon another material. In some embodiments, the at least onewheel is made of a rigid material, such as, but not limited to metalalloys, plastic or ceramic. In some embodiments, the at least one wheelis made from a rigid material coated with a flexible material. In otherembodiments, the at least one wheel is made of a rigid material and istoothed, wherein the teeth grip notches in the sides of a fastener orfixation device.

In yet another embodiment of the device, the device comprises a cam andlever system for propelling at least one fastener or fixation elementfrom the device into bone.

In some embodiments, said triggering mechanism comprises a means forregulating the propulsion source. For example, in some embodimentsthereof, regulating the pressure of the gas charging said chamber. Inother embodiments thereof, the triggering mechanism regulates the amountof compression of the spring. In still other embodiments thereof, thetriggering mechanism regulates the amount of contraction of the elasticelement.

In yet another embodiment, said trigger mechanism comprises a safety. Insome further embodiments, said safety prevents charging said chamberwith gas when the distal end of said barrel is not in contact with bone.In some further embodiments, said safety mechanism prevents actuation ofthe trigger mechanism when the distal end of said barrel is not incontact with bone.

In some embodiments, the barrel is interchangeable. For example, in someprocedures, several different diameters, sizes or types of fasteners orfixation elements may be needed. In order to facilitate delivery of saiddifferent fasteners or fixation elements, barrels specific for aparticular type of fastener or fixation element can be inserted into orremoved from the device. For example, a barrel specific for the deliveryof a K-wire may be initially installed in the device, such that a K-wirecan be driven into bone. Subsequently, suture anchors may be needed forthe attachment of tendon. Accordingly, the practitioner can remove theK-wire specific barrel from the device and replace it with a barrelspecific for a suture anchor of the desired size. In some embodiments,the interchangeable barrels for the device are disposable.

In some embodiments, the device comprises an openable breach proximal tothe barrel. Said openable breach allows the direct loading of at leastone fastener or fixation element into the chamber or barrel. In someembodiments, the interchangeable barrel is installed into or removedfrom the device through the openable breach.

In some embodiments, an implanting device of the present application issterilizable. In other embodiments, an implanting device of the presentapplication is disposable.

Another aspect of the present application relates to a method for thefixation of a fractured bone using the implanting device of theapplication.

In one embodiment, the method comprises fixation of bone fragments of along bone using an IM nail. The method comprises the steps of: providingan access point to the medullary canal of said long bone, reducing thebone fragments at the fracture, aligning the implanting device with saidmedullary canal at said access point, and actuating the triggermechanism of said implanting device to deliver an IM nail into saidmedullary canal, thereby fixing said bone fragments in said reducedstate. In some embodiments, said access point is percutaneous. In otherembodiments, said access point is open.

In a further embodiment, said access point is a hole in the bone. In astill further embodiment, said hole is created with a drill. In anotherstill further embodiment, said hole is created with an awl.

In another further embodiment, said long bone is selected from the groupconsisting of metatarsal bones and metacarpal bones, wherein saidmetatarsal bones and metacarpal bones include the phalanges.

In another embodiment, the method comprises fixation of bone fragmentsof a bone using at least one k-wire. The method comprises the steps ofreducing at least one bone fragment with at least one adjacent fragmentor the main body of the bone, aligning the implanting device with saidat least one bone fragment and said at least one adjacent fragment orthe main body of the bone, and actuating the trigger mechanism of saidimplanting device to deliver a k-wire affixing said at least one bonefragment to said at least one adjacent fragment or the main body of thebone, thereby fixing said at least one bone fragment in said reducedstate.

In a further embodiment, said bone is the humerus. In a still furtherembodiment, said at least one bone fragment is from the proximal end ofthe humerus.

In another further embodiment, said bone is the femur. In a stillfurther embodiment, said at least one bone fragment is from the head ofthe femur.

In yet another further embodiment, said bone is a carpal bone or atarsal bone.

In some further embodiments, the method comprises fixing two or morebones together to facilitate healing of ligaments. In some embodiments,the two or more bones are carpal bones or tarsal bones.

In some embodiments, the proximal end of the K-wire is left protrudingfrom the bone. In a further embodiment, a cross-pin fixation device isattached to the protruding proximal ends of the K-wires for furtherreduction or stabilization of the fracture.

Another aspect of the present application relates to a kit comprising animplantation device of the present application and a fastener orfixation element.

In one embodiment, the fastener or fixation element is selected from thegroup consisting of a k-wire, an IM nail, bone screw and a sutureanchor. In some embodiments, the kit further comprises a biocompatiblefiller or adhesive material.

In another embodiment, the kit further comprises a replaceable cartridgefor containing said at least one fastener or fixation element in saidchamber. In a further embodiment, said cartridge is disposable. Inanother further embodiment, said cartridge contains more than onefastener or fixation element.

In another embodiment, said implantation device is pneumatic. In afurther embodiment, said kit further comprises a propellant cartridge.In some embodiments, the propellant is compressed air.

FIG. 1 is a schematic view of one embodiment of the implanting device100. In some embodiments, the implanting device 100 is sterilizable. Inother embodiments, the implanting device 100 is disposable.

The implanting device 100 comprises a barrel 110 for propelling thefastener or fixation element into the bone, which is placed in contactwith, or in proximity to, the distal end 115 of the barrel 110. Thedevice further comprises a chamber 120 which holds the fastener orfixation element.

In some embodiments, the fastener or fixation element is held within areplaceable cartridge that is inserted into the chamber 120. In someembodiments, the cartridge holds a single fastener or fixation element.In other embodiments, the cartridge holds multiple fasteners or fixationelements. In particular embodiments, the cartridge is disposable.

In some embodiments, the device is adapted to be used with a single typeof fastener or fixation device. In other embodiments, the device isusable with multiple types fasteners or fixation devices. In furtherembodiments, the fasteners or fixation devices include, but are notlimited to k-wires, IM nails, screws and suture anchors.

In particular embodiments, the fasteners or fixation elements, or thecartridge that holds fasteners or fixation elements, is inserted intothe implanting device 100 through an access panel 130 at the proximalend 135 of the implanting device 100.

Pressure for propelling a fastener or fixation element down the barrel110 of the implanting device 100 is provided through a fitting 140 thatis affixed to the chamber 120. In some embodiments, the fitting 140comprises a tube. In other embodiments, the fitting 140 comprises acoupling for attaching to a gas source that provides a medicallyacceptable propellant gas. In still other embodiments, the fitting 140comprises both a tube and a coupling.

In some embodiments, the gas source is an external source. In otherembodiments, the gas source is a replaceable gas cartridge 150. In someembodiments, the replaceable gas cartridge 150 is insertable into thehandle 160 of the implanting device 100. In some embodiments, thereplaceable gas cartridge 150 is insertable through a port in the end165 of the handle 160 in other embodiments, the replaceable gascartridge 150 is insertable into a socket in the side or back of thehandle 160.

In some embodiments, the medically acceptable propellant gas is medicalgrade compressed air. In still other embodiments, the medicallyacceptable propellant gas comprises nitrogen, oxygen or carbon dioxide.In some embodiments the replaceable gas cartridge 150 is reusable. Inother embodiments, the replaceable gas cartridge 150 is disposable.

The chamber 120 is charged with propellant gas from the fitting 140 byactuation of a trigger mechanism 170. Actuation of the trigger mechanism170 allows the propellant gas to propel a fastener or fixation elementdown the barrel 110 and into the bone that is in contact with, or inproximity to, the distal end 115 of the barrel 110.

In some embodiments, the trigger mechanism 170 further comprises acontrol element for adjusting the pressure of the propellant gas that isreleased into the chamber 120.

Also, in some embodiments, the implanting device 100 comprises a safetymechanism such that the distal end of the barrel 115 must be in contactwith tissue in order for the implanting device 100 to operate. In someembodiments, unless the distal end of the barrel 115 is in contact withtissue, the trigger mechanism 170 cannot be actuated. In otherembodiments, unless the distal end of the barrel 115 is in contact withtissue, the trigger mechanism 170 can be actuated, but the chamber 120is not charged with propellant gas from the fitting 140.

In some other embodiments, the power for propelling a fastener orfixation element down the barrel of the implanting device 100 isprovided by a mechanical device such as a spring, an electrical devicesuch as a battery powered piston, or through a controlled explosion likein a firearm.

The present application is further illustrated by the following exampleswhich should not be construed as limiting. The contents of allreferences, patents and published patent applications cited throughoutthis application, as well as the Figures and Tables, are incorporatedherein by reference.

Example 1: Reduction and Fixation of Fractured Metacarpal Bone

A male subject presents with a fracture near the distal end of thesecond metacarpal bone on the left hand. The hand is x-rayed and thenature of the fracture indicates implantation of a bioabsorbable IM nailas the desired therapeutic approach.

The metacarpophalangeal joint is flexed 90 degrees exposing themetacarpal head, allowing direct access by the fixation device. Thefracture is reduced and held in place and the trigger mechanism of thefixation device is actuated, firing the IM nail through the metacarpalhead into the medullary canal of the phalanx, immobilizing the reducedfragments of the metacarpal in the correct position to allow union ofthe fragments at the fracture. The excess wire protruding is pulled out4 mm proximally and trimmed and then tapped in all the way underneaththe subchondral bone.

Example 2: Reduction and Fixation of Fractured Patella

A male subject presents with a fractured left patella. The knee isx-rayed and it is found that the patella is broken transversely intoupper and lower fragments. The decision is made to reduce the fractureand immobilize the fragments with k-wires using a tension bandprocedure.

Briefly, a longitudinal incision is made over the patella and thepatella is exposed. The fracture is reduced and held in place with atenaculum having the pincers contacting the top and bottom of thepatella along the centerline.

The implanting device, loaded with a cartridge comprising 2 mm diameterk-wires is contacted with the top of the patella and to one side of thetenaculum pincer. The implanting device is aimed to fire through bothfragments of the patella such that the distal end of a first k-wire willprotrude through the bottom of the patella. The trigger mechanism isactuated, forcing the first k-wire through the patella. The implantingdevice is moved to the top edge of the patella on the other side of thetenaculum pincer and a second k-wire is driven through the patella,parallel to the first.

A thin k-wire is passed behind the proximal ends of the 2 mm k-wiresprotruding from the top of the patella. The two ends of the thin k-wireare crossed over one another in front of the patella and one end ispassed behind the distal ends of the 2 mm k-wires protruding from thebottom of the patella. The two ends of the thin wire are broughttogether in front of the patella and twisted together until completelytaut. The distal ends of the 2 mm k-wires are trimmed and bent over thethin k-wire to secure it. The proximal ends of the 2 mm k-wires are alsotrimmed and soft tissue caps are placed over them. The incision over thepatella is sutured closed.

The above description is for the purpose of teaching the person ofordinary skill in the art how to practice the present application, andit is not intended to detail all those obvious modifications andvariations of it which will become apparent to the skilled worker uponreading the description. It is intended, however, that all such obviousmodifications and variations be included within the scope of the presentapplication, which is defined by the following claims. The claims areintended to cover the components and steps in any sequence which iseffective to meet the objectives there intended, unless the contextspecifically indicates the contrary.

What is claimed is:
 1. An implanting device for driving a fastener orfixation element into bone, comprising: a chamber for holding at leastone fastener or fixation element, a barrel having a proximal end and adistal end, wherein said proximal end is connected to said chamber forpropelling said fastener or fixation element from said chamber, apropellant source functionally connected to said chamber, and amechanism for releasing propellant from said propellant source into saidchamber and charging said chamber in order to propel said fastener orfixation element from said chamber through said barrel and driving saidfastener or fixation element into bone contacted with said distal end,wherein said propellant directly engages said fastener or fixationelement to drive the fastener or fixation element without the use of apiston.
 2. The device of claim 1, wherein said fastener or fixationelement is selected from the group consisting of a Kirschner wire, anintramedullary nail or a suture anchor.
 3. The device of claim 1,further comprising a replaceable cartridge for containing said at leastone fastener or fixation element in said chamber.
 4. The device of claim3, wherein said cartridge contains more than one fastener or fixationelement.
 5. The device of claim 1, wherein said propellant source is atube that connects to an external gas supply.
 6. The device of claim 1,wherein said propellant source is a replaceable canister of compressedgas.
 7. The device of claim 1, wherein said mechanism for releasingpropellant comprises a means for regulating the pressure of thepropellant charging said chamber.
 8. The device of claim 1, wherein saidmechanism for releasing propellant comprises a safety mechanism thatprevents charging said chamber with the propellant when the distal endof said barrel is not in contact with bone.
 9. The device of claim 8,wherein said safety mechanism prevents actuation of the triggermechanism when the distal end of said barrel is not in contact withbone.
 10. A method for the fixation of a fractured long bone with anintramedullary nail, comprising: providing an access point to themedullary canal of said long bone, reducing the bone fragments at thefracture, contacting the distal end of the barrel of the pneumaticimplanting device of claim 1 with said access point, aligning the barrelof said device with said medullary canal at said access point, andactuating the mechanism for releasing propellant of said implantingdevice to deliver an intramedullary nail into said medullary canal,thereby fixing said bone fragments in said reduced state.
 11. The methodof claim 10, wherein said access point is a hole in the bone.
 12. Themethod of claim 11, wherein said hole is created with a drill.
 13. Themethod of claim 11, wherein said hole is created with an awl.
 14. Themethod of claim 10, wherein said long bone is selected from the groupconsisting of metatarsal bones and metacarpal bones.
 15. The method ofclaim 14, wherein said metatarsal bones and metacarpal bones include thephalanges.
 16. A method for the fixation a fractured bone using at leastone Kirschner wire, comprising: reducing at least one bone fragment withat least one adjacent fragment or the main body of the bone, contactingthe distal end of the barrel of the pneumatic implanting device of claim1 with said at least one bone fragment, said at least one adjacentfragment or said main body of the bone, aligning the implanting devicewith said at least one bone fragment and said at least one adjacentfragment or said main body of the bone, and actuating the mechanism forreleasing propellant of said implanting device to deliver a Kirschnerwire affixing said at least one bone fragment to said at least oneadjacent fragment or the main body of the bone, thereby fixing said atleast one bone fragment in said reduced state.
 17. The method of claim16, wherein said bone is the humerus.
 18. The method of claim 17,wherein said at least one bone fragment is from the proximal end of thehumerus.
 19. The method of claim 16, wherein said bone is the femur. 20.The method of claim 19, wherein said at least one bone fragment is fromthe head of the femur.
 21. The method of claim 16, wherein said bone isa carpal bone or a tarsal bone.
 22. A kit comprising the implantationdevice of claim 1 and a fastener or fixation element.
 23. The kit ofclaim 22, wherein said fastener or fixation element is selected from thegroup consisting of a Kirschner wire, an intramedullary nail and asuture anchor.
 24. The kit of claim 22, further comprising a replaceablecartridge for containing said at least one fastener or fixation elementin said chamber.
 25. The kit of claim 24, wherein said cartridgecontains more than one fastener or fixation element.
 26. The kit ofclaim 22, wherein said implantation device is a pneumatic implantationdevice.
 27. The kit of claim 26, wherein said kit further comprises apropellant cartridge.